Custom-made devices are devices that are custom created for a particular patient, mostly starting with a patient's imaging, like CT or MRI and converting those models into digital models that are used for surgical planning. These models are then used to create the bespoke medical devices. Apart from eliminating the need for the large inventories needed to cover these surgeries, Custom devices offer more precise results, lower surgical times and reduced complications in comparison to their off-the shelf counterparts. These solutions have gained enormous acceptance in Maxillofacial and Orthopedic segments over the past years as literature and data on the value of these solutions becomes more available. Particularly, Class II and III implantable Custom-made devices have been demonstrated as a precise solution for Trauma and Oncology cases worldwide.
Covid 19 has catalyzed health technology advancements, pushing us to a Digital Transformation and remote interdisciplinary teams of surgeons and engineers are increasingly being used in surgical simulation and routine patient care.
Beyond telehealth, artificial intelligence, and machine learning, that are also listed as trends in healthcare for 2021, 3D printing and extended reality, including virtual reality, augmented reality, and mixed reality, have found very powerful applications in medical education, patient diagnosis, and treatment. Another very interesting functionality is the capability of 3D models both virtual and 3D printed to convey very clear explanations of the procedures and the pathologies to the patients and their families. An image is worth a thousand words and a 3D model is worth a thousand images.
According to the Global Interoperability Solutions in Healthcare Market Forecast, during the period of 2019-2025 Report by BIS, the market is expected to grow at a significant CAGR of 5.9%. The market has evolved dramatically with the increasing adoption of custom medical devices, emphasis on personalized care where there have been various government initiatives, more reimbursement, and clearer regulatory pathways as is the case in Australia that recently announced Regulatory changes for custom-made medical devices applying from 25 February 2021, as presented by TGA Australia.
Despite the technology being here, access is still a limiting factor especially in developing economies, where there is a lack of regulations and a big need to improve healthcare infrastructure. Taking advantage of the cloud solutions, we can join, the ever-growing number of 3D printing labs, Surgical Simulation Engineers, planning algorithms, and existing capabilities in Medical Device Manufacturing Companies to create these custom devices, and build a future where we can make custom the new standard, reducing human error, and lowering costs in healthcare expenditure.